Status:
COMPLETED
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Schering-Plough
Conditions:
HIV Infections
Hepatitis C
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatmen...
Detailed Description
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with c...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Treatment or suppression of opportunistic infections with standard drugs.
- Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines.
- Clinically indicated antibiotics.
- Short courses of steroids (< 21 days) for acute problems not related to hepatitis C.
- Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives.
Patients must have:
- HIV positivity.
- Documented hepatitis C virus.
- CD4 count <= 200 cells/mm3.
- No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C.
- Willingness to be followed for the duration of treatment and follow-up period.
Prior Medication:
Allowed:
- Prior AZT, ddI, and ddC.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Hepatitis B (HBsAg positive).
- Autoimmune hepatitis (FANA titer >= 1:160 and anti-smooth muscle antibody titer >= 1:160).
- Wilson's disease.
- alpha-1 antitrypsin deficiency.
- Hemochromatosis.
- Malignancy requiring systemic chemotherapy.
Concurrent Medication:
Excluded:
- Nonnucleoside analog therapy for HIV.
- Biologic response modifiers.
- Systemic cytotoxic chemotherapy.
- Chronic systemic steroid use.
Concurrent Treatment:
Excluded:
- Radiation therapy other than local irradiation to the skin.
Prior Medication:
Excluded:
- Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration).
- Acute therapy for an infection within 2 weeks prior to study entry.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1996
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00001035
End Date
September 1 1996
Last Update
April 30 2012
Active Locations (3)
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1
USC CRS
Los Angeles, California, United States
2
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 462025250
3
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016